Cleared Traditional

K200150 - Medline Powder-Free Orange Nitrile Pati...

K200150 is the FDA 510(k) clearance for Medline Powder-Free Orange Nitrile Pati... by Medline Industries, Inc.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K200150 · Medline Industries, Inc. · General Hospital
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Oct 2020
Decision
278d
Days
Class 1
Risk

K200150 is an FDA 510(k) clearance for the Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Medline Industries, Inc. (Northfield, US). The FDA issued a Cleared decision on October 26, 2020 after a review of 278 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K200150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2020
Decision Date October 26, 2020
Days to Decision 278 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 129d · This submission: 278d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K200150.
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